Urinary Excretion of Anthocyanins During Long Term Blueberry Feeding
2 other identifiers
interventional
17
1 country
1
Brief Summary
Essentially all of the published data on anthocyanin absorption in humans are from short term studies - a few days or less, most typically 24 h. However human studies demonstrating clinical effects are typically conducted for several weeks or even months. To examine how anthocyanin absorption and metabolism may be affected this study will examine urinary excretion of anthocyanins over one month, followed by a one week washout, and then one more dose of blueberry juice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 8, 2013
CompletedFirst Posted
Study publicly available on registry
February 12, 2013
CompletedFebruary 12, 2013
October 1, 2012
1 month
February 8, 2013
February 8, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anthocyanins and Phase 2 anthocyanin conjugates in urine
5 weeks
Secondary Outcomes (1)
White blood cell gene expression at start and end of study
4 weeks
Study Arms (1)
anthocyanin-free diet
OTHERMaintain anthocyanin-free diet throughout study. Day 1 to day 30, consume daily 250 ml single strength blueberry juice containing 229 mg anthocyanins, taken either as 1 morning dose or 1/3 dose morning, 1/3 mid-day and 1/3 evening. At d 31-38 continue anthocyanin-free diet. On d 39 consume daily dose.
Interventions
Dietary intervention
Eligibility Criteria
You may qualify if:
- Provided written consent (see: Information and Consent Form)
- Fluent in English
- Complete a confidential medical questionnaire (Appendix 6)
- Able and willing to abide by the dietary restrictions as described
- Able and willing to abide by the urine collection protocols as described
You may not qualify if:
- No written consent
- No confidential medical questionnaire
- Unable to comply with diet restrictions and other study requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Atlantic Food & Horticulture Research Centre
Kentville, Nova Scotia, B4N 1J5, Canada
Related Publications (1)
Kalt W, Liu Y, McDonald JE, Vinqvist-Tymchuk MR, Fillmore SA. Anthocyanin metabolites are abundant and persistent in human urine. J Agric Food Chem. 2014 May 7;62(18):3926-34. doi: 10.1021/jf500107j. Epub 2014 Jan 27.
PMID: 24432743DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Wilhelmina - Kalt, Ph.D.
Research Scientist
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2013
First Posted
February 12, 2013
Study Start
November 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
February 12, 2013
Record last verified: 2012-10